Stem Cells News: U.S. Study Shows That Overpriced Stem Cell Therapies To Treat Knee Pain Are Not As Effective As Ordinary Corticosteroid Injections!
Stem Cells News
: Osteoarthritis (OA) is a debilitating condition that affects millions of people worldwide, resulting in extensive joint damage and chronic pain. Despite the continuous advancements in diagnosis, medications, and short-term pain management solutions, the development of a disease-modifying OA drug has remained a formidable challenge. However, in recent years, stem cell therapy is being promoted by many dubious wellness clinics, providing hope for improved quality of life for many OA patients.
A new study conducted by a team of researchers at Emory University in collaboration with other recruitment sites across the United States has delved into the claims of mesenchymal stem cells (MSCs) as a revolutionary treatment for knee OA, a prevalent cause of chronic knee pain. Many medical charlatans peddling overpriced stem cell protocols claim that such treatment aims to leverage the regenerative capabilities of a patient's own cells to repair damaged joint tissue. Nevertheless, robust data from well-designed randomized controlled trials comparing stem cell therapy to the gold standard of corticosteroid injections (CSI) have been lacking.
The initial findings present a first-of-its-kind randomized clinical trial designed to identify the most effective source of cellular injections for knee OA. The research team compared three types of cellular preparations: autologous bone marrow aspirate concentrate (BMAC), autologous stromal vascular fraction (SVF), and allogeneic human umbilical cord tissue-derived mesenchymal stromal cells (UCT), against corticosteroid injections.
The primary outcome measures of the study were based on the visual analog scale (VAS) and the Knee Injury and Osteoarthritis Outcome Score (KOOS) for pain, assessed from baseline to one year. The fundamental question driving the research was whether cell-based therapies could surpass corticosteroids in the treatment of knee osteoarthritis at the one-year mark.
The results of the study indicated that all groups exhibited measurable improvements in pain and function, but there was no significant advantage in using any of the tested cell products compared to corticosteroid treatment at the 12-month follow-up in terms of changes in VAS pain score from baseline. Similarly, the analysis of the KOOS pain score yielded consistent results, with no significant differences between the groups at the 12-month mark in the change in score from baseline.
Further more there were a lot of unaddressed safety issues and adverse effects concerning the use of stem cell protocols.
Dr Scott D. Boden, the director of the Emory Orthopaedics and Spine Center and a senior author of the study, summarized the findings and told Stem Cell News
reporters at TMN, "The study demonstrated no superiority of any cell therapy over corticosteroids in reducing pain intensity over the course of a year. While there is much enthusiasm about the regenerative capacity of stem cells, the findings call into question the comparative effectiveness of various injections for knee osteoarthritis and underscore the importance of a personalized approach in selecting the right treatment for each patient's unique needs.&quo
One notable aspect of this study was its extensive evaluation of the safety of these procedures, meticulously monitoring every adverse reaction, from mild joint discomfort and swelling to unrelated hospitalizations. Importantly, the study found no study-related serious adverse events or symptomatic knee infections across any of the treatment groups during the follow-up period.
Dr Boden noted that future research papers stemming from the ongoing analysis of the data will explore whether specific subgroups of patients might benefit more from one treatment over another. These findings represent a significant step forward in shedding light on the comparative effectiveness of various OA treatment options. Furthermore, more in-depth analyses using techniques such as magnetic resonance imaging (MRI) and cellular analysis of each injectate will contribute to the development of standards of care in the field of knee osteoarthritis treatment.
The study aimed to address a critical issue in the field of orthopedics and regenerative medicine: the relative efficacy of different cellular therapies and corticosteroid injections in treating knee osteoarthritis. Despite the popularity and cost associated with various cellular therapies, there was a scarcity of literature establishing their relative effectiveness in comparison to each other and to corticosteroid injections.
The study, conducted as a phase 2/3, four-arm parallel, multicenter, single-blind, randomized, controlled clinical trial, involved 480 patients diagnosed with knee osteoarthritis, with Kellgren–Lawrence grades ranging from II to IV. Participants were randomized into one of the four cohorts, with a 3:1 distribution for each arm:
-Autologous bone marrow aspirate concentrate (BMAC) cohort (n=120) with a control group receiving corticosteroid injections (n=40).
-Allogeneic human umbilical cord tissue-derived mesenchymal stromal cells (UCT) cohort (n=120) with a corticosteroid injection control group (n=40).
-Stromal vascular fraction (SVF) cohort (n=120) with a corticosteroid injection control group (n=40).
The co-primary endpoints of the study were the visual analog scale (VAS) pain score and the Knee Injury and Osteoarthritis Outcome Score (KOOS) pain score at the 12-month follow-up compared to baseline. The primary aim was to determine whether cell-based therapies could outperform corticosteroid injections in the treatment of knee osteoarthritis.
The results of the study, involving 440 patients, revealed that none of the three orthobiologic injections showed superiority over the others or over corticosteroid injections at the 12-month follow-up.
The analysis of the VAS pain score and KOOS pain score produced consistent results, with no significant differences between groups.
The study also examined secondary outcome measures, such as EQ-5D and PROMIS-29, but found no significant differences between the cohorts receiving cellular therapies and the corticosteroid injection group.
Additionally, the study delved into exploratory outcomes, including analyzing the total nucleated cells injected and their viability for each cellular group. Single-cell RNA sequencing was performed on a subset of samples to explore differences and similarities in the cellular components of each product.
Intriguingly, despite efforts to categorize patients based on the severity of their arthritis, as measured by Kellgren–Lawrence grading, the study found that the grade of arthritis was not a reliable predictor of treatment success. The analysis did not reveal notable improvements in magnetic resonance imaging (MRI) scores in any treatment group compared to corticosteroid injections.
While the study offered essential insights into the comparative effectiveness of various treatment options for knee osteoararthritis, it also raised questions about the placebo effect and the potential impact of patient expectations on treatment outcomes. The placebo effect, particularly prevalent in interventions for knee osteoarthritis, makes it challenging to determine whether the observed improvements were due to the treatment or influenced by patients' expectations.
In conclusion, this study conducted by Emory University and its collaborators has contributed significantly to the understanding of the effectiveness and safety of various cellular therapies in the treatment of knee osteoarthritis. The results challenge the common belief in the superiority of cellular therapies over corticosteroid injections and emphasize the need for a personalized approach in selecting the most appropriate treatment for each patient.
The study's findings, along with ongoing research and further analyses, will continue to shape the standards of care for knee osteoarthritis and provide valuable guidance for both clinicians and patients seeking the most effective and safe treatment options for this debilitating condition. As science progresses and more data becomes available, the quest for a definitive and disease-modifying OA drug continues, and patients suffering from knee osteoarthritis can look forward to more informed decisions about their treatment options.
The study findings were published in the peer reviewed journal: Nature Medicine.
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